1. Field of the Invention
The present invention relates to devices and methods for vibration stimulation in at least one nasal cavity of a human subject, wherein a first and a second stimulation member are arranged to abut against tissue in the nasal cavities and to impart vibrations to said tissue in at least one nasal cavity.
2. Description of Background Art
Sphenopalatine ganglion is a parasympathetic ganglion found in the pterygopalatine fossa. It is one of four parasympathetic ganglia of the head and neck. It has the largest aggregate of neurons in the head outside of the brain. The sphenopalatine ganglion has been associated with a wide variety of pain problems that range from pain in the head and neck to pain of the low back. For example, electrical stimulation of the sphenopalatine ganglion has been shown to relieve acute severe cluster headache pain (Ansarinia et al, Headache; 2010, 50:1164-1174). In other examples, blocking of the sphenopalatine ganglion has been successful for reducing pain associated with headache.
The hypothalamus is a portion of the brain which lies beneath the thalamus and which contains a number of small nuclei with a variety of functions. One of the most important functions of the hypothalamus is to provide a link between the nervous system and the endocrine system via the pituitary gland (hypophysis). Several illnesses are associated with dysfunction in the hypothalamus, such as migraine, Ménière's disease, hypertension, cluster headache, arrhythmia, ALS, irritable bowl syndrome, sleep disorders, diabetes, obesity, multiple sclerosis, tinnitus, Alzheimer's disease, mood and anxiety disorders and epilepsy. In many cases the connection between the hypothalamus and the condition in question is not fully understood.
Cluster headache (CH), also called Horton's headache, is the most severe primary headache disorder. The disease is characterized by recurrent short-lasting attacks of torturous unilateral periorbital pain, mostly accompanied by ipsilateral autonomic signs such as nasal congestion, ptosis, lacrimation and redness of the eye. New surgical therapies have been tested. However, these treatments are invasive and can cause severe complications. The pathophysiology of CH is currently unknown, but involvement of the hypothalamus and the parasympathetic nervous system has been proposed (Leoux E et al, Orphanet J of Rare Diseases; 2008, 3:20).
Heart rhythm problems (heart arrhythmias) occur when the electrical impulses in the heart that coordinates the heartbeats do not work properly, causing the heart to beat too fast, too slow or irregularly. Heart arrhythmias are often harmless. Most people have occasional, irregular heartbeats that may feel like a fluttering or racing heart. However, some heart arrhythmias may cause bothersome, sometimes even life-threatening, signs and symptoms. Treatment form depends on the type and seriousness of the arrhythmia. Some people having the condition require no treatment. For others, treatment can include medication, making lifestyle changes and undergoing surgical procedures. A proposed reason for arrhythmias is a so called sympathetic imbalance, i.e. an imbalance in the sympathetic part of the autonomic nervous system, the heart rate is controlled by the hypothalamus via the vagus nerves so it seems plausible that such an imbalance is connected to hypothalamic activity.
There are several known devices for conducting treatments with systemic effects in human subjects. Devices for use in for example the nasal cavity often aim at achieving a local effect, such as decongesting the nasal mucosa, and may often be used in combination with a chemical substance. One example of a device for achieving a local effect on the nasal mucosa is disclosed in WO 2008/138997.
Devices are also known that by mechanical vibration affect tissue in a body cavity, e.g. in the ear or over a body surface. In US 2008/281238, a system for increasing activity on the fundamental brain is disclosed. The disclosed system comprises a first and a second vibration applying device, wherein the first vibration applying device applies vibrations having frequency components within an audible range to the auditory sense system of a living body. The second vibration applying device applies vibrations having super-high frequency components exceeding the audible range to another region than the auditory sense system, such as the nasal cavity.
In RU 2199303 there is disclosed a method of treating the neuroautonomic form of vasomotor rhinitis. More specifically, the method involves vibratory massage of the anterior third of the inferior and middle conchae at a frequency of 50 Hz for 1.5-2 minutes in combination with vibratory massage of certain biological active points (BAP:s) located in the hand, chin and near the nose. The instrument used for delivering the vibratory massage is described as a vibromassage instrument having a ball and a tip.
In US 2011/190668, methods and systems for non-invasive neuromodulation of the sphenopalatine ganglion is disclosed. An ultrasound transducer to treat migraine and cluster headache is described. An acoustic frequency, e.g. 0.44 MHz (typically in the range of 0.3 to 0.8 MHz), which permits the ultrasound to effectively penetrate through bone, is used.